Attendees: * denotes chair
Academia/Industry Representatives:
Shawn F. Dressman, Ph.D. - USP
Sylvia Gantt, PQRI Executive Secretary
Colin R. Gardner, Ph.D. - Merck - PhRMA
Sidney Goldstein. D.Sc - Duramed - GPhA
Richard C. Moreton, Ph.D. - Penwest - GPhA
David Pang, Ph.D. - AAPS
Richard P. Poska, R.Ph. - Abbott - ISPE
Nikki V. Mehringer - Lilly (by telephone) -PhRMA
FDA Representatives:
Ajaz Hussain, Ph.D.
Rajendra Uppoor. R.Ph.
Devinder S. Gill, Ph.D. (by telephone)
Welcome and Opening Remarks
Meeting convened at 10:10 a.m . Sidney Goldstein welcomed the group to the meeting. The new PQRI Executive Secretary, Sylvia Gantt, was introduced to the group.
Approval of Minutes
The Minutes from the November 21, 2000 were approved without modification.
Update of Steering Committee December 7, 2000 Meeting
Ajaz Hussain and David Pang reported on the activities of the December 7th, 2000 Steering Committee meeting. FDA requested the assistance of PQRI to address the issue of counterfeiting drugs. The steering Committee asked the members to suggest remedies to the issues and also to investigate what had been done by other agencies and organizations.
Operating policies and procedures for PQRI have been drafted and are in the process of being reviewed by the Steering Committee and the Board of Directors.
Concerns of DPTC
The Committee would like resolutions on publication guidelines regarding journals and authorship, conflict-of-interest and intellectual property issues.
Information in an article in the “Gold Sheet” (vol. 34, No. 12, December 2000), reporting on details at the PQRI Blend Uniformity Workshop in September 2000, was not reviewed by DPTC, Blend Uniformity Working Group or the Steering Committee. Some mechanisms should be instituted to address this issue
Action: Sid Goldstein will call William Paulson of Gold Sheet to discuss future procedure for dissemination of information.
Blend Uniformity Working Group
A memo from Tom Garcia of December 21, 2000, indicated that data mining might be a solution to blend uniformity issues. BUWG philosophy of the solid-dosage issue is that USP test is adequate, if done properly. Guidance for uniformity tests is absolutely required for proper compliance. DPTC viewed that: 1) prospective data is expensive; and 2) there can be problems with introspective data due to inaccuracies. DPTC felt that Tom Garcia’s proposal needed to be viewed with an eye toward other burdens and specifications and to determine if it is in the right line of thinking.
Finalization of the Survey summary is still some time in the future. It was agreed that it contained a good system of blinding. A draft of the survey results will be sent to the DPTC.
Manufacturing Changes Working Group
Ajaz Hussain discussed the risk management concepts to reduce CMC submission requirements and referred everyone to the November 2000 article in The Gold Sheet. He challenged this group to identify areas for exploration outside SUPAC.
Container/Closure Systems Working Group
The working group will supply the scientific basis for actual studies or will bring in data from existing reports on container/closure systems. Information gathering can be the first stage on managing broader packaging initiatives. Water vapor and oxidation are tow possible topics for the group. There are a number of issues falling directly under the vapor issue: for instance, the need to address the different blister packaging materials; why a cheaper packaging may not work as well as a more expensive one; and basic leeching issues. It was also mentioned that packaging companies could be an entirely new funding outlet for PQRI, if we can show the industry a quick success and show benefits for their participation.
Chris Moreton reported that there were eight individuals on their first Working Group conference call. It was determined that Julie Clifford of Alcon, ASTM, Don Klein from FDA, and Hugh Lockhard of USP should be invited to join the Group. The overall consensus of the Group was that they wanted to work closely with BACPAC. Overall, it was agreed that this Group was on the right track. Chris was to get back to them with the minutes of the conference call meeting, along with the minutes of this DPTC meeting. A workshop can be developed for the topics of this group.
DPTC requested to review the CVs of the working group in order to define projects to proceed, the time frame, as well as other details of the project.
Action: Sylvia Gantt to secure CVs from Chris Moreton and distributed to DPTC. Chris will discuss with the working group and report back to the group in two weeks. Rajendra Uppoor agreed to talk to Don Klein on this topic.
SUPAC
There are many different opportunities for projects in this area. There is a need to extend SUPAC back into the development process. Ajaz Hussain referred to an article he wrote, entitled “Calculating the Risk of Batch Failure in the Manufacture of Drug Products,” on procedures established by FDA. Ajaz would like to put together different scenarios. They would contain discerning what are the most routine changes that occur; i.e., class of change; and the need for a bio study. He further mentioned that granulation lines are far more expensive than compression lines when manufacturing. He also discussed how difficult the change is from granulation to compression.
FDA is working with SUPAC to bring the policies in line with the new regulations.
Action: Ajaz Hussain agreed to write the proposal before the DPTC 2/20/01 meeting.
In closing this topic for the day, it was discussed that FDA has two major concerns regarding risk factors - risk of shelf life and risk of bioequivalence. The November issue of “Gold Sheet” discussed testing at the June Workshop on that specific topic
Other Business
Ajaz Hussain will not be in attendance for the February 20th meeting. He will be traveling overseas.
Next Scheduled Meeting
The next scheduled meeting of the DPTC has been set for 10:00 a.m. on February 20th at AAPS headquarters in Arlington, VA.
The meeting adjourned at 2:30 p.m.